Sr Design Quality Engineer

We anticipate the application window for this opening will close on - 18 Sep 2026   Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Senior Design Quality Engineer, supporting Released Product Engineering (RPE) within the Acute Care & Monitoring (ACM) Operating Unit, drives product quality, reliability, and regulatory compliance through technical expertise and cross‑functional leadership. This role partners with R&D, regulatory, manufacturing, and program teams to ensure design changes and sustaining engineering activities meet internal quality standards and global regulatory requirements. The Senior Design Quality Engineer plays a critical role in applying Design Controls, Risk Management, and Change Control processes to evaluate, implement, and release product improvements across the ACM product portfolio. If you are passionate about solving complex technical problems, improving product quality, and collaborating across disciplines to deliver safe and reliable medical devices, this role offers an opportunity to make meaningful impact.

Critically review new and modified product designs to evaluate impact on product requirements, patient safety, reliability, and regulatory compliance. Ensure design changes are executed in accordance with Medtronic’s Quality Management System (QMS) and applicable global regulations including ISO 13485, EU MDR, and FDA Quality System Regulation (21 CFR Part 820). Lead cross-functional teams in the development and maintenance of risk management documentation including Risk Management Plans, hazard analyses, DFMEAs, and Risk Management Reports in accordance with ISO 14971. Support development and review of verification and validation strategies, including test plans, protocols, and reports, ensuring alignment with product requirements and applicable standards. Provide quality engineering support for sustaining engineering initiatives across multiple technical domains including electrical, software, mechanical, optical, algorithms, and human factors. Collaborate with cross-functional partners including R&D, Operations, Regulatory Affairs, Marketing, and Program Management to ensure timely and compliant execution of product changes. Apply Design for Reliability, Manufacturability, and Design for Six Sigma (DFSS) methodologies to improve product performance and reduce risk. Drive continuous improvement initiatives that enhance product quality, reliability, and manufacturing robustness. Provide technical guidance and mentorship to engineers on quality engineering principles, risk management practices, and design control requirements. MUST HAVE:

EDUCATION REQUIRED: Bachelor’s Degree.   YEARS OF EXPERIENCE: SENIOR LEVEL: 4+ years of Quality experience with a Bachelors Degree 2+ years of Quality experience with a Masters Degree   SPECIALIZED SKILLS OR EXPERIENCE:  Experience in the medical device industry or in a regulated industry with similar quality and regulatory requirements Working knowledge of Quality Management Systems compliant with ISO 13485, FDA Quality System Regulation (21 CFR 820), and EU MDR Experience applying risk management processes in accordance with ISO 14971 Familiarity with IEC 60601 and other applicable medical electrical equipment or product-specific standards Experience supporting design controls, verification and validation planning, and test execution for medical device products Experience with CAPA, root cause investigation, and failure